Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass (Ironsuppletion)

Rijnstate Hospital

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency

Treatments: Drug: Ferrous fumarate; Drug: Ferrous gluconate; Drug: Iron(III)carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT02271997

Ironsuppletion

Details and patient eligibility

About

Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.

Full description

Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.

Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.

Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin<20microgram/L)

Exclusion criteria

• iron deficiency peroperative, blood transfusions during study period, iron containing nutritional supplements except the standard multivitamins after bariatric surgery, decreased renal failure, excessive blood loss due to menstruation, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for noe of the medicinal products, psychiatric illness, pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Ferrous fumarate

Active Comparator group

Description:

40 patients receive ferrous fumarate 3 times a day 200mg

Treatment:

Drug: Ferrous fumarate

Ferrous gluconate

Active Comparator group

Description:

40 patients receive ferrous gluconate 2 times a day 695 mg

Treatment:

Drug: Ferrous gluconate

Iron(III)carboxymaltose

Active Comparator group

Description:

40 patients receive a single intravenous shot of ferinject

Treatment:

Drug: Iron(III)carboxymaltose